NCT00043550

Brief Summary

This 4-8 month study, with a 2-year follow up period, will compare sertraline (Zoloft®), venlafaxine (Effexor®), supportive-expressive psychotherapy, and placebo to determine which is more effective in treating major depression.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P25-P50 for phase_3 depression

Timeline
Completed

Started Nov 2001

Longer than P75 for phase_3 depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2001

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 12, 2002

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
8 years until next milestone

Results Posted

Study results publicly available

June 2, 2017

Completed
Last Updated

June 2, 2017

Status Verified

April 1, 2017

Enrollment Period

7.6 years

First QC Date

August 9, 2002

Results QC Date

August 26, 2015

Last Update Submit

April 28, 2017

Conditions

Depression

Keywords

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

  • Hamilton Rating Scale for Depression-17 Item

    Hamilton Rating Scale for Depression (HRSD) (Hamilton, 1960). We used the 17-item version of the 27-item HRSD, a measure of depression severity. The Structured Interview Guide was used to conduct the interviews (SIGH-D; Williams, 1988). The reliability and validity of the HRSD are well documented (Rabkin \& Klein, 1987). Interjudge reliability as assessed by interclass correlations was .92 in our sample. Total 17-item scores could range from 17-48 with higher scores indicating greater distress.

    symptoms assessed during past 7 days, measure taken at baseline, week 8 and week 16

Study Arms (3)

1 Sertraline/Venlafaxine

EXPERIMENTAL

Participants receive sertraline for the first 8 weeks. Participants will receive venlafaxine if they do not respond to sertraline by week 8

Drug: SertralineDrug: Venlafaxine

2 Supportive Expressive Therapy

ACTIVE COMPARATOR

Participants will receive supportive-expressive psychotherapy.

Behavioral: Supportive Expressive Therapy

3 Pill Placebo

PLACEBO COMPARATOR

Participants receive placebo.

Drug: Pill Placebo

Interventions

Supportive Expressive TherapyBEHAVIORAL

The aim of supportive-expressive psychotherapy is to help patients understand the causes of relationship conflicts in the context of a supportive relationship.

2 Supportive Expressive Therapy
SertralineDRUG

Participants will receive sertraline.

Also known as: Zoloft
1 Sertraline/Venlafaxine
Pill PlaceboDRUG

Participants will receive a pill placebo.

3 Pill Placebo
VenlafaxineDRUG

Participants will receive venlafaxine.

Also known as: Effexor
1 Sertraline/Venlafaxine

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Major Depressive Disorder diagnosis

You may not qualify if:

  • Psychotic or bipolar disorder diagnosis
  • Substance dependence in the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (7)

  • Barber JP, Muenz LR. The role of avoidance and obsessiveness in matching patients to cognitive and interpersonal psychotherapy: empirical findings from the treatment for depression collaborative research program. J Consult Clin Psychol. 1996 Oct;64(5):951-8. doi: 10.1037//0022-006x.64.5.951.

    PMID: 8916624RESULT

  • Kuprian N, Aafjes-van Doorn K, Gutterman D, Barber JP. Therapeutic immediacy in psychodynamic psychotherapy for depression: A mixed-method study. Psychotherapy (Chic). 2022 Dec;59(4):554-566. doi: 10.1037/pst0000452. Epub 2022 Aug 1.

    PMID: 35913883DERIVED

  • Solomonov N, Falkenstrom F, Gorman BS, McCarthy KS, Milrod B, Rudden MG, Chambless DL, Barber JP. Differential effects of alliance and techniques on Panic-Specific Reflective Function and misinterpretation of bodily sensations in two treatments for panic. Psychother Res. 2020 Jan;30(1):97-111. doi: 10.1080/10503307.2019.1585591. Epub 2019 Mar 1.

    PMID: 30821630DERIVED

  • Solomonov N, McCarthy KS, Gorman BS, Barber JP. The Multitheoretical List of Therapeutic Interventions - 30 items (MULTI-30). Psychother Res. 2019 Jul;29(5):565-580. doi: 10.1080/10503307.2017.1422216. Epub 2018 Jan 16.

    PMID: 29336228DERIVED

  • Zilcha-Mano S, Keefe JR, Chui H, Rubin A, Barrett MS, Barber JP. Reducing Dropout in Treatment for Depression: Translating Dropout Predictors Into Individualized Treatment Recommendations. J Clin Psychiatry. 2016 Dec;77(12):e1584-e1590. doi: 10.4088/JCP.15m10081.

    PMID: 28086005DERIVED

  • Zilcha-Mano S, Dinger U, McCarthy KS, Barrett MS, Barber JP. Changes in well-being and quality of life in a randomized trial comparing dynamic psychotherapy and pharmacotherapy for major depressive disorder. J Affect Disord. 2014 Jan;152-154:538-42. doi: 10.1016/j.jad.2013.10.015. Epub 2013 Oct 16.

    PMID: 24176534DERIVED

  • Barber JP, Barrett MS, Gallop R, Rynn MA, Rickels K. Short-term dynamic psychotherapy versus pharmacotherapy for major depressive disorder: a randomized, placebo-controlled trial. J Clin Psychiatry. 2012 Jan;73(1):66-73. doi: 10.4088/JCP.11m06831. Epub 2011 Nov 29.

    PMID: 22152401DERIVED

MeSH Terms

Conditions

DepressionDepressive Disorder, Major

Interventions

SertralineVenlafaxine Hydrochloride

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorDepressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

1-NaphthylamineAminesOrganic ChemicalsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsCyclohexanolsHexanolsFatty AlcoholsAlcoholsPhenethylaminesEthylaminesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicLipids

Limitations and Caveats

Two limitations are the relatively high level of attrition and small sample size for specific combinations within our moderation analysis.

Results Point of Contact

Title
Jacques P.Barber, PhD, Dean and Professor
Organization
Adelphi University, The Derner Institute of Advanced Psychological Studies
jbarber@adelphi.edu
516.877.4807

Study Officials

  • Jacques Barber, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2002

First Posted

August 12, 2002

Study Start

November 1, 2001

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

June 2, 2017

Results First Posted

June 2, 2017

Record last verified: 2017-04

Locations

US(1)